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Introducing the fundamentals of European medical device regulations – the Journal of Medical Device Regulation publishes an update of A Beginners' Guide to the European Medical Devices Directive (MDD)

London, 21 November 2011 -- Newcomers to the field of medical device regulation in Europe have a new guide to steer them through the maze of obligations and requirements. The Journal of Medical Device Regulation (JMDR) has released an update of its best-selling publication entitled A Beginners' Guide to the European Medical Devices Directive (MDD).

The Guide is prepared and written by RA expert Haroon Atchia from Quality First International. Haroon, a well-known author and consultant with comprehensive, hands-on experience in the field, examines the medical device regulations from a beginner’s perspective to help the reader understand and apply the general concepts of the European regulatory system.

The Guide introduces the European system of ‘New Approach’ Directives for medical device regulation and describes the role of the Competent Authority and the manufacturer in this system. It also discusses the regulatory hierarchy, including the requirement for an Authorised Representative for companies without an office in Europe and the use of non-governmental organisations such as Notified Bodies. It then concentrates on the Medical Devices Directive or MDD (Directive 93/42/EEC, as amended) by discussing its layout and structure, and how a manufacturer should conform to its requirements. Topics covered include: amending Directive 2007/47/EC; classification; Conformity Assessment Procedures; clinical evaluation; vigilance and post-market surveillance; CE marking and many more.

A Beginners’ Guide to the European Medical Devices Directive (MDD) is available through the JMDR bookstore at www.globalregulatorypress.com.

About the Journal of Medical Device Regulation

The Journal of Medical Device Regulation is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format. Full articles are only accessible to subscribers of the JMDR.

For Further Information

For more information on the Journal of Medical Device Regulation, please contact Marija Capek (tel: +49 (0)176 212 444 26) or visit the Global Regulatory Press website at www.globalregulatorypress.com.

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